QA New Product Introduction Responsible
Johnson & Johnson
Johnson & Johnson seeks a QA Specialist for New Product Introduction to provide quality assurance oversight of product transfers and implementation projects within Device Assembly and Parenteral Packaging at the Beerse, Belgium site. The role involves ensuring GMP compliance, quality standards, and regulatory requirements are met throughout the product lifecycle.
Responsibilities
- Serve as QA representative and primary quality contact for NPI, product transfer, and implementation projects
- Provide oversight throughout NPI lifecycle to ensure GMP compliance, quality standards, and regulatory alignment
- Review and approve GMP documentation including risk assessments, protocols, procedures, and project reports
- Support product and process transfer into commercial manufacturing and ensure quality release of NPI batches
- Represent Quality during inspections, audits, and participate in deviation, CAPA, and change control activities
Requirements
- University degree in Pharmaceutical Sciences, Chemical Sciences, Biological Sciences, Engineering, or related scientific discipline
- 2–5 years pharmaceutical industry experience in GMP-regulated manufacturing
- Strong quality mindset with attention to detail and accuracy
- Familiarity with Quality Risk Management principles and cGMP regulations
- Cross-functional team collaboration and project management experience
- Fluent Dutch and English, both written and spoken
- Strong analytical, problem-solving, and communication skills
Vacature geplaatst op 2 dagen geleden
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